ct-guided stereotactic body radiation therapy and mri-guided stereotactic body radiation therapy for prostate cancer, mirage study

Conditions: Prostate Adenocarcinoma

Summary: this phase iii trial studies compares ct-guided stereotactic body radiation therapy and mri-guided stereotactic body radiation therapy (sbrt) in treating prostate cancer. image-guided sbrt is a standard treatment for prostate cancer, which combines imaging of the cancer within the body with the delivery of therapeutic radiation doses produced on a linear accelerator machine. imaging modalities for image-guided sbrt can be either computed tomography imaging (ct), magnetic resonance imaging (mri), or a combination of the two. this research is being done to help determine whether there are benefits to mri-guidance over ct-guidance in patients who are receiving the same radiation dose by sbrt to treat prostate cancer.

primary objective: i. to determine whether (mri)-guided stereotactic body radiotherapy (sbrt) improves acute physician-scored genitourinary (gu) toxicity when compared with standard computed tomography (ct)-guided sbrt for prostate cancer (pca). secondary objectives: i. to determine whether there are differences in acute grade \>= 2 gastrointestinal (gi) toxicity as assessed by the common terminology criteria for adverse events (ctcae) version 4.03 scale, following mri-guided sbrt versus ct-guided sbrt. ii. to determine whether there are differences in 5-year cumulative incidences of late grade \>= 2 gu and gi physician-reported toxicity, following mri-guided sbrt versus ct-guided sbrt. iii. to quantify the temporal changes in patient-reported quality of life (qol) outcomes, as assessed by the expanded prostate cancer index-26 (epic-26), international prostate symptom scores (ipss), and sexual health inventory for men (shim) qol indices, following mri-guided sbrt. iv. to determine whether there are differences in 5-year biochemical recurrence-free survival (bcrfs) following mri-guided sbrt. v. to observe the proportion of sbrt fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy. outline: patients are randomized to 1 of 2 groups. group i: patients undergo 5 fractions of ct-guided sbrt over 14 days in the absence of disease progression or unacceptable toxicity. group ii: patients undergo 5 fractions of mri-guided sbrt over 14 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then yearly thereafter.

Eligibility criteria:
inclusion criteria: * histologically confirmed, clinical localized adenocarcinoma of the prostate * no evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis) * staging workup as recommended by the national comprehensive cancer network (nccn) on the basis of risk grouping: * low risk: no staging workup required * favorable intermediate-risk: ct abdomen/pelvis if memorial sloan kettering cancer center (mskcc) nomogram predicts \>10% probability of lymph node involvement * unfavorable intermediate-risk: technetium bone scan, ct abdomen/pelvis if mskcc nomogram predicts \>10% probability of lymph node involvement * high-risk: technetium bone scan, ct abdomen/pelvis if mskcc nomogram predicts \>10% probability of lymph node involvement * advanced imaging studies (i.e. prostate-specific membrane antigen positron emission tomography \[psma pet\] and axumin scan) can supplant a bone scan if performed first * ability to understand, and willingness to sign, the written informed consent exclusion criteria: * patients with neuroendocrine or small cell carcinoma of the prostate * patients with any evidence of distant metastases. note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator * prior cryosurgery, high intensity focused ultrasound (hifu) or brachytherapy of the prostate * prior pelvic radiotherapy * history of crohn's disease, ulcerative colitis, or ataxia telangiectasia * contraindications to mri, including: * electronic devices such as pacemakers, defibrillators, deep brain stimulators, cochlear implants; * metallic foreign body in the eye or aneurysm clips in the brain; * severe claustrophobia